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Last Updated: September 20, 2020

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No   Start Trial   Start Trial COADMINISTERING WITH ALLOPURINOL TO REDUCE SERUM URIC ACID (SUA) BELOW 4 MG/DL; BELOW 6MG/DL IN PATIENTS HAVING URIC ACID DEPOSITS; AND/OR BELOW 6MG/DL WITH SUA INTRADAY CHANGE MORE THAN 50% AND/OR ADVERSE EVENT RATE LESS THAN 15%
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-002 Aug 18, 2017 DISCN Yes No   Start Trial   Start Trial TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-001 Aug 18, 2017 DISCN Yes No   Start Trial   Start Trial TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Start Trial   Start Trial MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Johnson and Johnson
McKinsey
AstraZeneca
Mallinckrodt

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